This study will test the effects of a medication called tolcapone on cognitive, behavioral,
and language problems seen in patients with frontotemporal dementia (FTD). Tolcapone
increases the amount of dopamine, a brain chemical that may be lowered in FTD. The study will
see if tolcapone can improve thinking, behavior, and language in people with FTD and will
look at the effects of the drug on brain activity.
Patients with FTD who are between 40 and 85 years of age may be eligible for this study.
Participants will be seen as outpatients at the Columbia University Medical Center
approximately one a week for 4 weeks. They take tolcapone or a placebo (a look-alike pill
with no active ingredient) during study week 1. During study week 3, those who took placebo
during week 1 now take tolcapone for 1 week and those who took tolcapone now take placebo. In
addition, patients undergo the following tests and procedures:
- Neurological tests to evaluate attention, problem-solving and memory. These tests are
repeated several times during the course of the study.
- Test to look for a gene that affects the amount of dopamine in the brain, using blood
samples collected in a previous study.
- Blood draws four times during the study.
- Functional MRI (fMRI) to learn about changes in brain regions that are involved in
performing tasks. For fMRI, the patient lies on a table that can slide in and out of the
scanner, a narrow metal cylinder surrounded by a magnetic field. The procedure takes
about 60 minutes and is performed four times over the course of the . FMRI involves
taking pictures of the brain during MRI while the subject performs a task so that
changes in the brain that occur during these tasks can be studied.
Phase:
Phase 2
Details
Lead Sponsor:
Columbia University
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)